Dose Finding Study to Treat High Phosphate Levels in the Blood.

Hyperphosphatemia Clinical Trial

Official title:

A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081534
• Other study ID #: D5613C00001
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: August 2020
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period

Description:

The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.

The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.

There are 7 parallel treatment arms in the study with bid and od treatment regimens.

Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.

The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Females and males aged =18 years

2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months

3. Prescribed and taking at least 3 doses of phosphate binder per day

4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening

5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening

6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.

2. Serum parathyroid hormone >1200 pg/mL

3. Significant metabolic acidosis

4. Clinical signs of hypovolemia at randomization

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Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• AZD1722
AZD1722, oral tablet
• Placebo
Placebo bid, double dummy technique

Locations

Country	Name	City	State
Poland	Research Site	Bialystok
Poland	Research Site	Czestochowa
Poland	Research Site	Dzialdowo
Poland	Research Site	Legnica
Poland	Research Site	Lublin
Poland	Research Site	Radom
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Zamosc
Poland	Research Site	Zary
Poland	Research Site	Zgierz
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Hlohovec
Slovakia	Research Site	Kosice
Slovakia	Research Site	Piestany
Slovakia	Research Site	Puchov
Slovakia	Research Site	Senica
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Doncaster
United Kingdom	Research Site	Exeter
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Detroit	Michigan
United States	Research Site	Downey	California
United States	Research Site	Flushing	New York
United States	Research Site	Los Angeles	California
United States	Research Site	Maspeth	New York
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Springfield	Massachusetts
United States	Research Site	Tampa	Florida
United States	Research Site	Voorhees	New Jersey
United States	Research Site	Whittier	California
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Countries where clinical trial is conducted

United States,  Poland,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Phosphate Levels	Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment	End of wash out (pre randomization value) to end of treatment (Day 29)
Secondary	Change From Baseline in Calcium x Phosphorus Product	Change from baseline (end of wash out) in calcium x phosphorus product	End of wash out (pre randomization value) to end of treatment (Day 29)